Haematology Analytical Performance Specifications


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Measurand Lower limit Upper limit
WCC + or - 0.5 ≤ 5.0 x109/L + or - 10% > 5.0 x109/L
RCC + or - 0.2 ≤ 2.0 x1012/L + or - 10% > 2.0 x1012/L
Hb + or - 5 ≤ 100 g/L + or - 5% > 100 g/L
Hct + or - 0.04 ≤ 0.20 + or - 20% > 0.20
MCV + or - 5 ≤ 50 fL + or - 10% > 50 fL
MCH + or - 2 ≤ 20 pg + or - 10% > 20 pg
MCHC + or -30 ≤ 300 g/L + or - 10% > 300 g/L
RDW-CV + or - 2 ≤ 10% + or - 20% > 10%
PLT + or - 25 ≤ 100 x109/L + or - 25% > 100 x109/L
MPV + or - 2 ≤ 10 fL + or - 20% > 10 fL
Measurand Lower limit Upper limit
PT + or -2.0 ≤ 10.0 sec + or - 20% > 10.0 sec
INR/POC INR + or - 0.3 ≤ 2.0 ratio + or - 15% > 2.0 ratio
APTT + or - 10 ≤ 40 sec + or - 25% > 40 sec
Fibrinogen + or - 0.20 ≤ 1.0 g/L + or - 25% > 1.0 g/L
Thrombin Time + or - 3 ≤ 12 sec + or - 25% > 12 sec
Factor II, V, VII, VIII, IX, X, XI, XII + or - 3 ≤ 10 IU/dL + or - 30% > 10 IU/dL
D-Dimer (Automated) + or - 0.25 ≤ 0.50 DD mg/L + or - 50% > 0.50 DD mg/L
D-Dimer (Automated) + or - 0.5 ≤ 1.0 FEU mg/L + or - 50% > 1.00 FEU mg/L
Measurand Lower limit Upper limit
Hb A2 + or - 0.3 ≤ 2.0% + or - 10% > 2.0%
Hb F + or - 0.5 ≤ 1.50% + or - 30% > 1.50%
Hb Variant + or - 4 ≤ 20% + or - 20% > 20%
Measurand Lower limit Upper limit
WCC + or - 0.5 ≤ 5.0 x109/L + or - 10% > 5.0 x109/L
Neutrophils/Granulocytes + or - 1.0 ≤ 10.0% + or - 10% > 10.0%
Lymphocytes + or - 2.0 ≤ 10.0% + or - 20% > 10.0%
Monos/Eosinos/Basos/LUC/IG + or - 3.0 ≤ 10.0% + or - 30% > 10.0%
Measurand Lower limit Upper limit
APTT + or - 9.0 ≤ 30 sec + or - 30% >30 sec
APTT Screen Ratio + or - 0.3 ≤ 0.9 ratio + or - 30% > 0.9 ratio
DRVVT screen + or - 9.0 ≤ 30 sec + or - 30% > 30 sec
DRVVT screen ratio + or - 0.3 ≤ 0.9 ratio + or - 30% > 0.9 ratio
Measurand Lower limit Upper limit
Protein C functional + or - 12 ≤ 60% + or - 20% > 60%
Protein S Total Antigen + or - 10 ≤ 40% + or - 25% > 40%
Protein S Free Antigen + or - 10 ≤ 40% + or - 25% > 40%
Protein S Free Functional + or - 10 ≤ 40% + or - 25% > 40%
AT Functional + or - 10 ≤ 40% + or - 25% > 40%
Measurand Lower limit Upper limit
APCR APTT, APCR APTT V, APCR RVVT, APCR RVVT V, APCR Staclot Assessed on interpretation Assessed on interpretation
Measurand Lower limit Upper limit
FVIII:C + or - 3 ≤ 10% + or - 30% > 10%
VWF:Ag + or - 3 ≤ 10% + or - 30% > 10%
VWF:RCo + or - 4 ≤ 10% + or - 40% > 10%
VWF:CB + or - 4 ≤ 10% + or - 40% > 10%
VWF:Activity + or - 4 ≤ 10% + or - 40% > 10%
Measurand Lower limit Upper limit
Inhibitor level BU Assessed on interpretation Assessed on interpretation
Measurand Lower limit Upper limit
Closure time Assessed on interpretation Assessed on interpretation
Measurand Lower limit Upper limit
APTT + or - 10 ≤ 40 sec + or - 25% > 40 sec
Anti Xa + or - 0.1 ≤ 0.4 U/mL + or - 25% > 0.4 U/mL
Measurand Lower limit Upper limit
DTI + or - 25 ≤ 100 ng/mL + or - 25% > 100 ng/mL
Measurand Lower limit Upper limit
Anti Xa + or - 25 ≤ 100 ng/mL + or - 25% > 100 ng/mL
Measurand Lower limit Upper limit
Anti Xa + or - 25 ≤ 100 ng/mL + or - 25% > 100 ng/mL
Measurand Lower limit Upper limit
Factor XIII Assessment on diagnostic interpretation Assessment on diagnostic interpretation
Measurand Lower limit Upper limit
G6PD assay + or - 3.0 ≤ 10.0 U/g Hb + or - 30% > 10.0 U/g Hb
Measurand Lower limit Upper limit
ESR + or - 3.0 ≤ 10.0 mm/hr + or - 30% > 10.0 mm/hr
Measurand Lower limit Upper limit
Percentage + or - 0.6 ≤ 2.0% + or - 30% > 2.0%
Absolute count + or - 21.0 ≤ 70.0 + or - 30% > 70.0 x109/L
Measurand Lower limit Upper limit
Percentage + or - 1.0 ≤ 10.0% + or - 10% > 10.0%
Absolute count + or - 10 ≤ 100 + or - 10% > 100 x109/L
Measurand Lower limit Upper limit
Clotting Times Assessment under review Assessment under review
Measurand Lower limit Upper limit
Clotting Times Assessment under review Assessment under review
Measurand Lower limit Upper limit
%CD34 + or - 0.05 ≤ 0.20% + or - 25% > 0.20%
Total CD34 + or -5 ≤ 20.0 + or - 25% > 20.0 μL